A first patient has been enrolled into Veryan’s MIMICS-3D Registry, which aims to provide real-world data to support the existing positive clinical trial data.
Background
A previous visitor to our pages, Veryan’s BioMimics 3D nitinol stent features a unique three-dimensional helical geometry, based on pioneering research by Prof Colin Caro at Imperial College London into the link between blood flow mechanics and vascular disease. Its uniquely helical shape is designed to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the vessel’s endothelium. The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to facilitate shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localised strains that in a straight stent may lead to stent fracture and chronic vascular injury.
In the earlier Mimics trial, the Kaplan Meier (KM) survival estimate of freedom from loss of primary patency at two years was 72% for BioMimics 3D subjects vs. 55.0% for the control arm. The difference in survival estimate between the two groups by log rank test was significant (P<0.05). Importantly, there was no increase in the KM estimate of clinically driven target lesion revascularization (CDTLR) rate in the BioMimics arm between 12 and 24 months (9% at both time-points) compared to a 3-fold increase (8% at 12 months and 24% at 24 months) in the straight stent control arm.
Newly-recruiting MIMICS-3D is a prospective, multicentre, observational registry to evaluate the BioMimics 3D Self-Expanding Stent System in the treatment of peripheral arterial disease. The Registry will evaluate safety, effectiveness and device performance within a real-world clinical population in a minimum of 500 patients across Europe.
Investigator comments
The MIMICS-3D Registry principal investigator(PI), Michael Lichtenberg MD (Arnsberg, Germany) commented: “Having been able to enroll a significant number of patients into the MIMICS-2 IDE Study I am delighted to be the PI of the MIMICS-3D Registry, and particularly pleased to be able to enrol the first patient into the MIMICS-3D Registry. The three studies within the MIMICS programme will provide a combined database of clinical experience that I expect to provide significant validation of the unique helical shape of BioMimics 3D and the clinical benefits of swirling flow.”
Company comments
Chas Taylor, Veryan CEO commented: “This milestone is another significant step in the Veryan clinical programme. Veryan is committed to seeking high quality, compelling clinical data for our BioMimics 3D stent. We have been overwhelmed by the enthusiasm shown across Europe by clinicians wishing to participate in the MIMICS-3D Registry which illustrates the growing understanding of, and belief in, the clinical benefits of swirling flow.”
Source: Veryan Medical Ltd.
published: September 15, 2016 in: Clinical Studies/Trials, Vascular